Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

N/ACompletedNCT00203515

Tyco Healthcare Group1,000 enrolled

Overview

The purpose of the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.

Over 1 million catheter-associated urinary tract infections (CAUTIs) occur annually in U.S. healthcare facilities and account for approximately 40% of the nosocomial infections. This investigation is a multi-center, blinded, prospective, randomized, controlled, parallel comparison of the intervention catheter (Tyco Healthcare DOVER Silver Foley catheter) to a usual care catheter and another commercially available silver-coated catheter. 1000 subjects total will be randomized at the multiple study centers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,000

Conditions

Urinary Tract Infections

Interventions

Standard Latex Foley CatheterDEVICE

Silver Coated Latex Foley CatheterDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is at least 18 years of age. * Subject is expected to be catheterized with a 14, 16 or 18 French Foley catheter for at least 72 hours. * Subject or his/her legally authorized representative is able to grant informed consent to participate in this investigation. Exclusion Criteria: * Subjects who present with ongoing, active, symptomatic UTI. * Subjects with a known or suspected allergy to silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis. * Subjects with a known or suspected allergy to natural rubber latex or natural rubber latex compounds causing delayed hypersensitivity reactions or contact dermatitis. * Subjects known to be pregnant. * Prisoners.

Locations (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Catheter associated urinary tract infection (UTI)

Secondary Outcomes

Catheter tolerance

Cost of care

Data from ClinicalTrials.gov

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